An Action can be Rejected at two different Stages of a CAPA: Implementing and Under Signing By QA
Action Approval/Rejection cycle - Implementing Status
The Responsible Person (John Smith in this example) will be able to perform the assigned Action once the CAPA reaches the Implementing status from his dashboard.
This can easily be found by
- Filtering on CAPA Actions
- Toggling to Action required
The user can then selection Close Action from the yellow Action drop down box next to the Action title:
They will then need to electronically sign off the Action, providing details of the Actions Performed that allow the Action to be closed.
After they signs off, the action will be in its Pending Approval status and will no longer be displayed on the Users dashboard anymore. (Only if the User has chosen to only have "Action Required" items displayed in the filters option, otherwise the "Pending Approval" CAPA Action will still be displayed).
At this moment, the QA (also John Smith in this example) will be requested to approve or reject the completed Action:
If the Action is Rejected, it will become available once again as "Open" on the Action Responsible User Dashboard.
Please note: The requirement for Action approval from QA depends on a Module Configuration.
CAPA > Module Settings > Signature Settings > Action Sign off for QA
Action Approval/Rejection cycle - Under Signing by QA Status
While the CAPA is on the Under Signing by QA status, the QA has the option of rejecting specific Actions, not only the option to reject the CAPA as a whole.
If while on the CAPA Details page, the QA decides to click on Reject as a QA:
A pop-up will appear, where the QA will need to:
- Provide a Reason
- Select the Custom Actions to be Rejected
- Save it
Where can I see the rejection notification?
First we head back to John Smith's Scilife dashboard
- Click on Dashboard
- Select My Emails. Here you can see all email notifications the user has received.
- Click on the closed envelope icon to open the email and view the contents. (This notification will also be present in the User's e-mail.)
This is how the email notification will be displayed within Scilife, when opened:
This information also becomes available on the CAPA Audit Trail: